On September 19, 2015 Genmab A/S (OMX: GEN) reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for ofatumumab (Arzerra) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL) (Press release, Genmab, SEP 19, 2015, View Source [SID:1234507503]). Schedule your 30 min Free 1stOncology Demo! The application was submitted to the FDA by Novartis under our ofatumumab collaboration in July 2015.
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Priority Review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The FDA aims to complete its review of the ofatumumab sBLA within the time set by the Prescription Drug User Fee Act (PDUFA) and has given a target date for completion of their review of January 21, 2016.
"We are very pleased that the FDA has granted Priority Review for ofatumumab, which means ofatumumab could potentially be available as a maintenance therapy for patients suffering from relapsed CLL relatively soon," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to receiving FDA’s feedback on the application."
The application is based on interim results from a Phase III study, PROLONG (OMB112517) which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL. Results from this trial were presented at the 2014 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
About CLL
CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately 1 in 4 cases of leukemia1,2. Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment3.
About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.
In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.
Arzerra is not approved anywhere in the world as maintenance therapy for relapsed chronic lymphocytic leukemia.
Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).
Arzerra is marketed under a collaboration agreement between Genmab and Novartis.